[Federal Register Volume 60, Number 104 (Wednesday, May 31, 1995)]
[Rules and Regulations]
[Pages 28348-28351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13251]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4167/R2129; FRL-4952-2]
RIN 2070-AB78
Tebuconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance of 0.05 part per million
(ppm) for residues of the fungicide tebuconazole (alpha-[2-(4-
chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol) in or on the raw agricultural commodity bananas. Miles, Inc.,
submitted a petition pursuant to the Federal Food, Drug and Cosmetic
Act (FFDCA) for the regulation to establish [[Page 28349]] a maximum
permissible level for residues of the fungicide.
EFFECTIVE DATE: This regulation becomes effective May 31, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 3F4167/R2129], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251. A copy of any objections and hearing requests
filed with the Hearing Clerk should be identified by the document
control number and submitted to: Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. In person, bring copy of objections and hearing requests to
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
3F4167/R2129]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Connie B. Welch, Product
Manager (PM) 21, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 227, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6900; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of October 21, 1993 (58 FR 54353), which announced
that Miles, Inc., Agricultural Division (formerly Mobay Corp.,
Agricultural Chemicals Division), P.O. Box 4913, Kansas City, MO 64120-
0013, had submitted pesticide petition (PP) 3F4167 to EPA requesting
that the Administrator, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish a
tolerance for residues of the fungicide tebuconazole (alpha-[2-(4-
chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol) in or on the raw agricultural commodity bananas at 0.05 ppm.
There were no comments received in response to the notice of
filing. The scientific data submitted in the petition and other
relevant material have been evaluated. The toxicological data
considered in support of the tolerance include:
1. A 90-day rat feeding study with a no-observed-effect-level
(NOEL) of 34.8 milligrams per kilogram of body weight per day (mg/kg
bw/day) (400 ppm) and a lowest-effect-level (LEL) of 171.7 mg/kg bw/day
(1,600 ppm) in males, based on decreased body weight gains and
histological changes in the adrenals. For females, the NOEL was 10.8
mg/kg bw/day (100 ppm), and the LEL was 46.5 mg/kg bw/day (400 ppm)
based on decreased body weights, decreased body weight gains, and
histological changes in the adrenals.
2. A 90-day dog feeding study with a NOEL of 200 ppm (73.7 mg/kg
bw/day in males and 73.4 mg/kg bw/day in females) and a LEL of 1,000
ppm (368.3 mg/kg bw/day in males and 351.8 mg/kg bw/day in females).
The LEL was based on decreases in mean body weights, body weight gains,
and food consumption, and an increase in liver N-demethylase activity.
3. A 1-year dog feeding study with a NOEL of 1 mg/kg bw/day (40
ppm) and a LEL of 5 mg/kg bw/day (200 ppm), based on lenticular and
corneal opacity and hepatic toxicity in either sex (the current
Reference Dose was determined based on this study). A subsequent 1-year
dog feeding study, using lower doses to further define the NOEL for
tebuconazole, defines a systemic LOEL of 150 ppm (based on adrenal
effects in both sexes) and a systemic NOEL of 100 ppm.
4. A 2-year rat chronic feeding study defined, a NOEL of 7.4 mg/kg
bw/day (100 ppm), and a LEL of 22.8 mg/kg bw/day (300 ppm) based on
body weight depression, decreased hemoglobin, hematocrit, MCV and MCHC,
and increased liver microsomal enzymes in females. Tebuconazole was not
oncogenic at the dose levels tested (0, 100, 300, 1,000 ppm).
5. A rat oral developmental toxicity study with a maternal NOEL of
30 mg/kg bw/day and a LEL of 60 mg/kg bw/day based on elevation of
absolute and relative liver weights. For developmental toxicity, a NOEL
of 30 mg/kg bw/day and an LEL of 60 mg/kg bw/day was determined, based
on delayed ossification of thoracic, cervical and sacral vertebrae,
sternum, fore and hind limbs and increase in supernumerary ribs.
6. A rabbit oral developmental toxicity study with a maternal NOEL
of 30 mg/kg bw/day and an LEL of 100 mg/kg bw/day based on depression
of body weight gains and food consumption. A developmental NOEL of 30
mg/kg bw/day and an LEL of 100 mg/kg bw/day were based on increased
post-implantation losses, from both early and late resorptions and
frank malformations in eight fetuses of five litters.
7. A mouse oral developmental toxicity study with a maternal NOEL
of 10 mg/kg bw/day and an LEL of 20 mg/kg bw/day based on a
supplementary study indicating reduction in hematocrit and histological
changes in liver. A developmental NOEL of 10 mg/kg bw/day and an LEL of
30 mg/kg bw/day based on dose-dependent increases in runts/dam at 30
and 100 mg/kg bw/day.
8. A mouse dermal developmental toxicity study with a maternal NOEL
of 30 mg/kg bw/day and an LEL of 60 mg/kg bw/day based on a
supplementary study indicating increased liver microsomal enzymes and
histological changes in liver. The NOEL for developmental toxicity in
the dermal study in the mouse is 1,000 mg/kg bw/day, the highest dose
tested (HDT).
9. A two-generation rat reproduction study with a dietary maternal
NOEL of 15 mg/kg bw/day (300 ppm) and a LEL of 50 mg/kg bw/day (1,000
ppm) based on depressed body weights, increased spleen hemosiderosis,
and decreased liver and kidney weights. A reproductive NOEL of 15 mg/kg
bw/day (300 ppm) and an LEL of 50 mg/kg bw/day (1,000 ppm) were based
on neonatal birth weight depression.
10. An Ames mutagenesis study in Salmonella that showed no
mutagenicity with or without metabolic activation.
11. A micronucleus mutagenesis assay study in mice that showed no
genotoxicity.
12. A sister chromatid exchange mutagenesis study using CHO cells
that was negative at dose levels 4 to 30 micrograms per milliliter
without activation or 15 to 120 micorgrams per milliliter with
activation. [[Page 28350]]
13. An unscheduled DNA synthesis (UDS) study that was negative for
UDS in rat hepatocytes.
Additionally, a mouse oncogenicity study at dietary levels of 0,
20, 60, and 80 ppm for 21 months did not reveal any oncogenic effect
for tebuconazole at any dose tested. Because the Maximum Tolerated Dose
(MTD) was not reached in this study, the study was classified as
supplementary. A followup mouse study at higher doses (0, 500, and
1,500 ppm in the diet), with an MTD at 500 ppm, revealed statistically
significant incidences of hepatocellular adenomas and carcinomas in
males and carcinomas in females. The initial and followup studies,
together with supplementary data submitted by Miles, Inc., were
classified as core minimum.
The Office of Pesticide Programs' Health Effects Division's
Carcinogenicity Peer Review Committee (CPRC) has classified
tebuconazole as a Group C carcinogen (possible human carcinogen). This
classification is based on the Agency's ``Guidelines for Carcinogen
Risk Assessment'' published in the Federal Register of September 24,
1986 (51 FR 33992). The Agency has chosen to use the reference dose
calculations to estimate human dietary risk from tebuconazole residues.
The decision supporting classification of tebuconazole as a possible
carcinogen (Group C) rather than a probable carcinogen (Group B) was
primarily based on the statistically significant increase in the
incidence of hepatocellular adenomas, carcinomas, and combined
adenomas/carcinomas in both sexes of NMRI mice both by positive trend
and pairwise comparison at the HDT, and the structural correlation with
at least six other related triazole pesticides that produce liver
tumors.
The Reference Dose (RfD) is established at 0.01 mg/kg of body
weight (bwt)/day, based on a no-observed-effect level (NOEL) of 1.00
mg/kg bwt/day and an uncertainty factor of 100. The NOEL is based on a
1-year dog feeding study that demonstrated lenticular and corneal
opacity and hepatic toxicity as an endpoint effect. The Theoretical
Maximum Residue Contribution (TMRC) from the current action is
estimated at 0.000019 mg/kg bwt/day and utilizes 0.19% of the RfD for
the general population of the 48 States. The TMRCs for the most highly
exposed subgroups, children (1 to 6 years old) and children (7 to 12
years old) are 0.000060 mg/kg bwt/day (0.60% of the RfD) and 0.000032
mg/kg bwt/day (0.32% of the RfD), respectively.
The nature of the residue in bananas is adequately understood. An
adequate analytical method using gas chromatography is available for
enforcement purposes.
The enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual,
Volume II (PAM II). Because of the long lead time for publication of
the method in PAM II, the analytical methodology is being made
available in the interim to anyone interested in pesticide enforcement
when requested from: Calvin Furlow, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 1132,
CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-
5232.
There is no reasonable expectation that secondary residues will
occur in milk, eggs, or meat of livestock and poultry since there are
no livestock feed items associated with this action.
There are presently no actions pending against the continued
registration of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
will protect the public health. Therefore, the tolerance is established
as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issue(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under docket
number [PP 3F4167/R2129] (including objections and hearing requests
submitted electronically as described below). A public version of this
record, including printed, paper versions of electronic comments, which
does not include any information claimed as CBI, is available for
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document
control number [PP 3F4167/R2129], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests can be sent
directly to EPA at:
opp-D[email protected]
A copy of electronic objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any objections and hearing requests received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all objections and hearing requests submitted directly in
writing. The official rulemaking record is the paper record maintained
at the address in ADDRESSES at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to a rule (1) having an
annual effect on the economy of $100 million or [[Page 28351]] more, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local or tribal governments or communities (also
known as ``economically significant''); (2) creating serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement, grants, user fees, or loan programs; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 18, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.474, by amending the table therein by adding and
alphabetically inserting an entry for bananas, to read as follows:
Sec. 180.474 Tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl]-alpha-
(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol); tolerances for
residues.
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Parts per
Commodity million
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Bananas.................................................... 0.05
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[FR Doc. 95-13251 Filed 5-30-95; 8:45 am]
BILLING CODE 6560-50-F